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Bridging the Gap by Transitional Care

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Counseling
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus Type 2 focused on measuring Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females
  • 18 to 85 years of age
  • Historical diagnosis of type 2 diabetes mellitus greater than one year
  • HbA1c concentration ≥ 8%
  • Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
  • Patient with provider and prescriptions filled within CCHS

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnancy
  • Major illness or debility, that prohibits the subject from participating in the study
  • History of any hemoglobinopathy that may affect determination of HbA1c
  • Non-English speaking patients

Sites / Locations

  • John H. Stroger Jr. Hospital of Cook County

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pharmacist Counseling

Standard therapy

Arm Description

Pharmacist Counseling includes but is not limited to: Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity

Standard therapy: Nurses distribute a education pamphlet on diabetes

Outcomes

Primary Outcome Measures

Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure

Secondary Outcome Measures

Change in A1c after 90 days
A1c measure as % and lipid panel 90 days following pharmacist counseling To demonstrate an improvement in health literacy following pharmacist counseling on diabetes To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling
Change in BP after 90 days
BP in mm/Hg
Change in lipids after 90 days
Lipid measurements in mg/dL

Full Information

First Posted
April 5, 2011
Last Updated
July 10, 2023
Sponsor
Cook County Health
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1. Study Identification

Unique Protocol Identification Number
NCT01330121
Brief Title
Bridging the Gap by Transitional Care
Official Title
Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
Detailed Description
It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge. Standard therapy: Nurses distribute a education pamphlet on diabetes. Pharmacist Counseling includes but is not limited to: Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist Counseling
Arm Type
Active Comparator
Arm Description
Pharmacist Counseling includes but is not limited to: Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Standard therapy: Nurses distribute a education pamphlet on diabetes
Intervention Type
Other
Intervention Name(s)
Pharmacist Counseling
Intervention Description
Pharmacist Counseling includes but is not limited to: Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Primary Outcome Measure Information:
Title
Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management
Description
The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure
Time Frame
up to 120 days
Secondary Outcome Measure Information:
Title
Change in A1c after 90 days
Description
A1c measure as % and lipid panel 90 days following pharmacist counseling To demonstrate an improvement in health literacy following pharmacist counseling on diabetes To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling
Time Frame
up to 90 days
Title
Change in BP after 90 days
Description
BP in mm/Hg
Time Frame
up to 90 days
Title
Change in lipids after 90 days
Description
Lipid measurements in mg/dL
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females 18 to 85 years of age Historical diagnosis of type 2 diabetes mellitus greater than one year HbA1c concentration ≥ 8% Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County Patient with provider and prescriptions filled within CCHS Exclusion Criteria: Type 1 diabetes mellitus Pregnancy Major illness or debility, that prohibits the subject from participating in the study History of any hemoglobinopathy that may affect determination of HbA1c Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Fogelfeld, M.D.
Organizational Affiliation
John H. Stroger Hospital of Cook County, Division of Endocrinology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mansi Shah, PharmD
Organizational Affiliation
John H. Stroger Hospital of Cook County, Department of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CaTanya Norwood, R.PH
Organizational Affiliation
John H. Stroger Hospital of Cook County, Department of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H. Stroger Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Bridging the Gap by Transitional Care

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